BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HALUX EXLITE MINOR SURGERY LIGHT

    K Number: K896961 · Decision Feb 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    92
    Review Days
    69

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    Basic Information

    Device Name
    HALUX EXLITE MINOR SURGERY LIGHT
    K Number
    K896961
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Jedmed Instrument Co.
    Date Received
    December 15, 1989
    Decision Date
    February 22, 1990
    Product Code
    GBC
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GBC Lamp, Surgical, Incandescent

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